Vitreoretinal Surgery Under Sub-Tenon's AnesthesiaPhase 3PrecedexNCT02327156
Dexmedetomidine as an Adjuvant for Sub-Tenon's Anesthesia
A Phase 3 study testing dexmedetomidine in people with Vitreoretinal Surgery Under Sub-Tenon's Anesthesia, run by Magrabi Eye & Ear Hospital.
Trial summary
The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitreoretinal Surgery Under Sub-Tenon's Anesthesia
- What is being tested?
- dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Nov 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- satisfactory akinesia
- predictable surgical time to be less than 3 hours were inclusion criteria for this study
Who cannot join
- incorporated patients younger than 18 years,
- patients with a single eye,
- history of sleep apnea,
- severe cardiac disease, and
- drug abuse or
- if there was any contraindication to LA.
About this study
Official title: The Effect of a Low-dose Dexmedetomidine as an Adjuvant to Levobupivacaine in Patients Undergoing Vitreoretinal Surgery Under Sub-Tenon's Anesthesia
The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint.
Read the detailed description
Background: The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint.
Methods: The investigator investigated 60 patients subjected to vitreoretinal surgery under sub-Tenon's anesthesia. The patients were randomly divided equally into 1 of 2 groups conferring to the local anesthesia (LA) solution used to receive either 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline (group L) or 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline (group LD). The total volume of the LA solution used was 5 mL. Motor block (akinesia) and sensory block durations were evaluated until the return of normal motor and sensory function. The sedation level was assessed during the surgery period and 24 hours postoperatively together with the degree of postoperative pain and the efficiency of postoperative analgesia. The sleep quality of the first postoperative night was assessed using the Consensus Sleep Diary (CSD).
- Being tested
- dexmedetomidine
- Keywords
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Also called Precedex, 200 μg per 2 mL; Hospira, USA
adding dexmedetomidine to the local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| group L | No intervention | receive 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline |
| group LD | Active comparator | 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the motor and sensory block durations
expected to be extended in group LD
Measured: participants will be followed for the duration of hospital stay, an expected average of 24 hours
Secondary outcomes (1)
sleep quality of the 1st postoperative night
improved the sleep quality
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreoretinal Surgery Under Sub-Tenon's AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magrabi Eye & Ear Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf M Ghali, Magrabi Eye & Ear Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327156
- Sponsor's protocol ID
- MEEC-IRB-2014-1
- Acronym
- Precedex
- Status last verified
- Dec 2014
- First submitted
- 18 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Low-dose Dexmedetomidine as an Adjuvant to Levobupivacaine in Patients Undergoing Vitreoretinal Surgery Under Sub-Tenon's Anesthesia
- ClinicalTrials.gov ID
- NCT02327156
- Acronym / sponsor ID
- Precedex / MEEC-IRB-2014-1
- Keywords
- Dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Magrabi Eye & Ear HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint.
Detailed description
Background: The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint.
Methods: The investigator investigated 60 patients subjected to vitreoretinal surgery under sub-Tenon's anesthesia. The patients were randomly divided equally into 1 of 2 groups conferring to the local anesthesia (LA) solution used to receive either 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline (group L) or 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline (group LD). The total volume of the LA solution used was 5 mL. Motor block (akinesia) and sensory block durations were evaluated until the return of normal motor and sensory function. The sedation level was assessed during the surgery period and 24 hours postoperatively together with the degree of postoperative pain and the efficiency of postoperative analgesia. The sleep quality of the first postoperative night was assessed using the Consensus Sleep Diary (CSD).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group L | No intervention | –receive 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline |
| group LD | Active comparator | Drug: dexmedetomidine4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- satisfactory akinesia
- predictable surgical time to be less than 3 hours were inclusion criteria for this study
Key exclusion criteria (6 listed)
- incorporated patients younger than 18 years,
- patients with a single eye,
- history of sleep apnea,
- severe cardiac disease, and
- drug abuse or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidineAlso: Precedex, 200 μg per 2 mL; Hospira, USAadding dexmedetomidine to the local anesthetic | Drug | group LD |
Primary outcome
the motor and sensory block durations
Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
expected to be extended in group LD
1 secondary outcome
sleep quality of the 1st postoperative night
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexmedetomidine in people with Vitreoretinal Surgery Under Sub-Tenon's Anesthesia, run by Magrabi Eye & Ear Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the motor and sensory block durations (time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.